Catalog Number

IS1251

Brand Name

Bard® BrachySource® I-125 Implant Seeds in Isosleeve™ Delivery System

Version/Model Number

IS1251

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 15, 2021

Issuing Agency

In GS1

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K093663,K093663

Product Code

KXK

Product Code Name

Source, brachytherapy, radionuclide

Public Device Record Key

3bb0563e-fdde-4ec0-b370-cb5fcb387e3e

Public Version Date

July 16, 2021

Public Version Number

4

DI Record Publish Date

October 05, 2015

Package DI Number

10801741078337

Quantity per Package

1

Contains DI Package

00801741078330

Package Discontinue Date

June 15, 2021

Package Status

Not in Commercial Distribution

Package Type

Other